L10 LED Light Source Ref 0220-220-300 Instructions for United States Users Rev G Mar 2019

Contents Warnings and Cautions... 1 Cautions...2 Warnings: General...2 Warnings: Laser...3 Operating a Light Source...4

Product Description and Intended Use...5 Indications...5 ENV Mode Requirements...6 IRIS Mode Requirements...7 General Compatibility...8 Console Features...9

Setup... 11 Connecting the AC Power Cable ... 12 Connecting to the Camera Control Unit... 12 Connecting a Light Cable... 13 Connecting an IRIS Ureteral Kit... 14

Operation... 15 Powering the Console On and Off... 15 Activating White Light Mode... 16 Placing the Light Source in Standby Mode... 16 Activating ENV Mode... 17 Activating IRIS Mode... 20

Using AIM IC-GREEN in ENV Mode... 23 ICG Indications for Use... 24 ICG Contraindications... 24 Pharmacology... 24 Warning... 24 Adverse Reactions... 24 Precautions... 25 Required Supplies... 26 ICG Preparation... 26 ICG Dosage... 26 Administration... 27 ICG Overview... 27 ICG Storage... 27

Error Messages... 28 Troubleshooting... 29 Maintenance... 31 Cleaning the Light Source... 31 Inspection... 31 Checking the ESST Feature... 32 Replacing the Fuses... 33 Storage... 33 Expected Service Life... 33 Disposal... 33 Recycling Diagram... 34

Technical Specifications... 35 Electromagnetic Compatibility... 36

Symbol Definitions... 40

Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meaning and should be carefully reviewed: Warning

Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.

Caution

Indicates risks to the equipment. Failure to follow cautions may result in product damage.

Note: Clarifies the instructions or presents additional useful information. An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual. A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel.

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Cautions To avoid potential damage to this device, please note the following cautions. 1. 2. 3. 4. 5.

Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, see the standard warranty. Never sterilize the console. The delicate electronics cannot withstand a sterilization procedure. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines. Attempt no maintenance or adjustments that are not specifically detailed in this user manual. Ensure that any modifications or repairs are carried out by persons authorized by Stryker. No modification of this equipment is allowed by the user.

Warnings: General To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following general warnings. 1. 2.

Must be a qualified physician to use this equipment. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device. 3. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment. 4. Do not position the console so that it is difficult to disconnect the power cord from the supply mains. 5. Never block the rear or side vents of the console. Failure to follow this instruction can result in device damage or a possible fire. 6. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground. 7. Multiple portable socket-outlets shall not be placed on the floor. 8. Never use this equipment in the presence of flammable or explosive gas. 9. Disconnect the console from the electrical outlet when inspecting fuses or making any repairs. Refer all repairs to authorized personnel. 10. Do not remove covers on the console, as doing so may cause damage to electronics and/or electric shock.

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Warnings: Laser IMPORTANT SAFETY NOTICE - LASER RADIATION: The L10 LED Light Source with Advanced Imaging Modality Technology (or “L10 AIM Light Source”) is a laser product that uses a Class 1 laser (IRIS mode) and a Class 1M laser (ENV mode). Use of controls or performance of procedures other than those specified herein can result in hazardous laser radiation exposure and can cause severe eye injury to the patient or user. To prevent exposure to laser radiation, follow all warnings and guidelines presented below and throughout this user manual. 1.

Observe the warning label shown below (located on the rear panel).

2. 3.

Protect the L10 AIM Light Source against unqualified use. Wear eye protection as appropriate. Refer to any applicable regional regulations or standards for personal protective equipment. Do not manipulate tissue while ENV mode is activated. The 1588 AIM Video Camera is intended to visualize tissue manipulation only while ENV mode is off. Do not view the laser output in ENV mode with telescopic optical instruments (for example, microscopes or magnifiers). Do not direct the laser output in ENV mode into an area where such instruments are likely to be used. Do not activate ENV mode when the endoscope is outside of the patient’s body. When ENV mode is activated, never look into the following apertures or direct the light emitted from the apertures toward another person: • the light cable connection on the light source (if the cable is not attached) • the end of the light cable (if the SafeLight adapter is attached) • the endoscope tip When ENV mode is activated, never leave a SafeLight adapter attached to the light cable without an endoscope attached. Laser radiation can continue to emit from the adapter. Power off the light source (or place it in Standby mode and disable ENV mode and IRIS mode) before connecting or removing the light cable, endoscope, or disposable fibers.

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6. 7.

8.

9.

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Operating a Light Source Please note the following special warnings to avoid user or patient injury or product damage when using a light source. IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES: Before operating this device, please read this operating manual thoroughly and carefully. When using a light source, fire and/or severe injury may result to the patient, user or inanimate objects if the instructions in this manual are not followed. All light sources can generate significant amounts of heat (exceeding 41 °C/106 °F) at the scope tip, the scope light post, the light cable tip, and/or near the light cable adapter. Higher levels of brightness result in higher levels of heat. Adjust the brightness level of the camera and the monitor to the minimum brightness necessary to adequately illuminate the surgical site. In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity. Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user. In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire. Always place the light source in Standby mode and disable ENV mode before the scope is removed from the light cable or the device is unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in Standby mode, and therefore may still result in fire or burns to the patient, user, or inanimate objects. The warranty is void if any of the above warnings or cautions are disregarded.

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Product Description and Intended Use The Stryker L10 LED Light Source with Advanced Imaging Modality Technology (or “L10 AIM Light Source”) is a light-generating unit designed to illuminate surgical sites in the following applications: visible light (White Light mode), near-infrared fluorescence (ENV mode), and near-infrared transillumination (IRIS mode). • White Light mode: The light source uses light-emitting diode (LED) technology to generate bright, crisp light in the visible light spectrum that is intended to illuminate surgical sites during endoscopic procedures. The light is delivered to the surgical site through an endoscope via a fiber optic light cable. • ENV mode: The light source uses laser technology to generate light in the near-infrared light spectrum, which is intended to enable fluorescence imaging of anatomy that has been targeted with the contrast agent indocyanine green. The light is delivered to the surgical site through an endoscope via a fiber optic light cable. • IRIS mode: The light source uses laser technology to generate light in the near-infrared light spectrum that is intended to transilluminate the ureter during open or laparoscopic surgical procedures. The light is delivered to the surgical site via a disposable fiber. The light source is equipped with a safety feature that minimizes light output if the fiber optic light cable is not connected to the scope adapter, which prevents exposure to laser radiation, high-intensity light, and accidental burns. For more information, see the section Checking the ESST Feature.

Indications The L10 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L10 AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the L10 AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization. The L10 AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures. 5

ENV Mode Requirements The equipment listed below is required to achieve the intended results when using the light source in Endoscopic Near-Infrared Visualization (ENV) mode. Any model listed for the camera head and laparoscope may be used. Intended results will not be achieved if any equipment is substituted. ENV mode is intended to be used with a contrast agent drug called indocyanine green (ICG). AIM IC-GREEN® (NDC # 17478-801-02) includes the required ICG supplies. See the Using AIM IC-GREEN in ENV Mode section for more detail. Note: In the United States, the L10 LED Light Source with AIM Technology and SafeLight Fiber Optic Cable are indicated for use only with AIM IC-GREEN. For users outside the U.S., refer to Stryker user manual P27009. Before using ENV mode, read and be familiar with the warnings and instructions provided with each device in the system. Light Source 0220-220-300 L10 LED Light Source with AIM Technology Camera Control Unit 1588-010-000 1588 AIM Camera Control Unit1 Camera Head 1588-210-105 1588 AIM Camera Head, C-Mount1 1588-610-122 1588 AIM Camera Head with Integrated Coupler1 1588-710-105 1588 AIM Inline Camera Head, C-Mount1 Coupler 1588-020-122 AIM Coupler, 18 mm, C-Mount2 Laparoscope 0502-537-010 0502-537-030 0502-937-010 0502-937-030

AIM, 5.4 mm, 0°, HD Laparoscope, 30 cm3 AIM, 5.4 mm, 30°, HD Laparoscope, 30 cm3 AIM, 10 mm, 0°, HD Laparoscope, 33 cm3 AIM, 10 mm, 30°, HD Laparoscope, 33 cm3

AIM SafeLight Cable 0233-050-300 AIM SafeLight Fiber Optic Cable, 5.0 mm x 10 ft (3.05 m)4 Indocyanine Green AIM IC-GREEN5 1

See Stryker user manual P29923 (English) or P29924 (multilingual). 2 See Stryker user manual P30104 . 3 See Stryker user manual P27900. 4 See Stryker user manual P27701. 5 See AIM IC-GREEN instructions for use packaged with NDC # 17478-801-02.

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IRIS Mode Requirements The equipment listed below is required to achieve the intended results when using the light source in Infrared Illumination System (IRIS) mode during laparoscopic surgical procedures. Any model listed for the camera control unit, camera head, coupler, and laparoscope may be used. Intended results will not be achieved if any equipment is substituted. Of the equipment listed below, only the light source and disposable fiber are required to achieve the intended results when using IRIS mode during open surgical procedures. Before using IRIS mode, read and be familiar with the warnings and instructions provided with each device in the system. Light Source 0220-220-300 L10 LED Light Source with AIM Technology Camera Control Unit 1588-010-000 1588 AIM Camera Control Unit1 1488-010-000 1488 HD 3-Chip Camera Control Unit2 1488-010-001 1488 HD 3-Chip Camera Control Unit with DVI Fiber Output2 Camera Head 1588-210-105 1588 AIM Camera Head, C-Mount1 1588-610-122 1588 AIM Camera Head with Integrated Coupler1 1588-710-105 1588 AIM Inline Camera Head, C-Mount1 1488-210-105 1488 HD 3-Chip Camera Head, C-Mount2 1488-610-122 1488 HD 3-Chip Camera Head with Integrated Coupler2 1488-710-105 1488 HD 3-Chip Inline Camera Head, C-Mount2 Coupler 1588-020-122 AIM Coupler, 18 mm, C-Mount3 1488-020-122 1488 HD 18 mm Coupler, C-Mount4 Laparoscope 0502-537-010 0502-537-030 0502-937-010 0502-937-030

AIM, 5.4 mm, 0°, HD Laparoscope, 30 cm5 AIM, 5.4 mm, 30°, HD Laparoscope, 30 cm5 AIM, 10 mm, 0°, HD Laparoscope, 33 cm5 AIM, 10 mm, 30°, HD Laparoscope, 33 cm5

Light Cable Any Stryker light cable Disposable Fiber 0220-180-518 IRIS Ureteral Kit6 7

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See Stryker user manual P29923 (English) or P29924 (multilingual). See Stryker user manual P18966 (English) or P18972 (multilingual). 3 See Stryker user manual P30104. 4 See Stryker user manual P18968. 5 See Stryker user manual P27900. 6 See Stryker user manual P26059. 2

Note: IRIS mode is also compatible with the following Intuitive Surgical® robotic camera systems: Intuitive Surgical® Robotic System da Vinci® Xi System da Vinci® Si System with Firefly™ mode IRIS sensitivity is enhanced in the Intuitive Surgical® da Vinci® System by the use of Firefly™ mode. The Stryker light source and disposable fiber listed above are required to use Intuitive Surgical® robotic camera systems with IRIS mode.

General Compatibility • All Stryker light cables are compatible with the L10 AIM Light Source when used in White Light mode or IRIS mode. ENV mode requires the AIM SafeLight cable (0233-050-300). • Using the proper scope adapter, the Stryker light cable can connect the light source system to any flexible or rigid endoscope. Before using another manufacturer’s equipment, thoroughly read the accompanying documents for all warnings and instructions.

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Console Features The features of the L10 AIM Light Source are described below.

Front Panel

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2

3

4

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1. Power Button

Powers the unit on and off

2. IRIS Connectors

For connecting the light source ends of the IRIS Ureteral Kit (0220-180-518). Location of Class 1 laser emissions when IRIS Ureteral Kit is connected and IRIS mode is activated.

3. Touchscreen

Provides user controls and system feedback

4. Light Cable Connection

For connecting the light-source end of the light cable. Location of Class 1M laser emissions when AIM SafeLight cable is connected and ENV mode is activated.

5. Jaw Handle

Opens and closes the clamp in the light cable connection

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Rear Panel 1

2

SDC

CCU

3

4

5

1. SDC connection

Connects to Stryker SDC for voice and device control with a USB A-to-B cable

2. CCU connection

Connects to Stryker 1588 AIM Camera Control Unit with the provided USB A-to-A cable

3. Equipotential Ground Plug

Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

4. Fuse Panel

Contains two T 5.0AH 250V (slow blow, high breaking capacity 1500A) fuses

5. AC Inlet

Connects to AC mains with the provided, separable power cord

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Setup Stryker considers instructional training, or inservice, an integral part of the L10 AIM Light Source. Your local Stryker sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance. To schedule an inservice, contact your local Stryker representative after your equipment has arrived. Setting up the L10 AIM Light Source involves four steps: • • • •

Connecting the AC power cable Connecting a USB cable to the Camera Control Unit Connecting a Light Cable Connecting an IRIS Ureteral Kit Always connect the light source to an appropriate power source, using a hospital-grade power cord. Loss of AC power will cause the camera to shut down and the surgical image to be lost. Only connect items to the light source that have been specified for use with the light source. Connecting incompatible equipment may cause unexpected results. When the light source is used with other equipment, leakage currents may be additive. To minimize leakage current that may travel to the patient or user, any Type CF applied part should be used only with other Type CF applied parts. Ensure that all systems are installed according to the requirements of IEC 60601‑1. Equipment which employs RF communications may affect the normal function of the light source. When choosing a location for the console, consult the Electromagnetic Compatibility section to ensure proper function. Always set up the console in a location that allows adequate ventilation (airflow) to the console. Insufficient ventilation may cause the console to overheat and shut down. The console must also be positioned on its feet; do not operate the unit upside down or on its side.

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Connecting the AC Power Cable 1. 2.

Plug in the AC power cord to the AC Inlet on the rear console panel. Plug in the other end of the AC cord to a hospital-grade outlet.

Connecting to the Camera Control Unit To activate ENV mode, the L10 AIM Light Source must be connected to the 1588 AIM Camera. White Light mode and IRIS mode do not require connection to the camera. Note: The 1588 AIM camera head can be programmed to control some functions of the L10 AIM Light Source, such as toggling Active/Standby or adjusting some settings in ENV mode. Contact a Stryker representative for more information about enabling this advanced feature. 1.

Using a USB A-to-A cable, connect the CCU port on the L10 AIM Light Source to the Light Source port on the 1588 AIM Camera Control Unit. 1588 AIM Camera Control Unit

L10 AIM Light Source SDC

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CCU

Connecting a Light Cable To activate ENV mode, an AIM SafeLight cable (0233-050-300) must be connected to the light source. White Light mode and IRIS mode will function when other Stryker light cables are connected. Power off the light source (or place it in Standby mode and disable ENV mode and IRIS mode) before connecting or removing the light cable or endoscope. Keep fingers away from the light cable connection as the clamp may inadvertently deploy and cause injury. The light cable connection on the light source emits a Class 1M laser when ENV mode is activated. To assure proper and safe laser application, connect only the AIM SafeLight cable to the light source. Do not attempt to use any other fiber optic light cables with ENV mode. Do not operate the light source in ENV mode with an AIM SafeLight cable that is cut or damaged. If the AIM SafeLight cable breaks during operation, place the light source in Standby mode and disable ENV mode, then replace the cable. 1. 2.

Make sure the light source is powered off, or place it in Standby mode and disable ENV mode. Lock open the clamp in the light cable connection by turning the jaw handle clockwise until it stops.

3.

Insert a clean, dry light cable into the cable connection until the jaw clamps the cable in place. Pull gently on the cable to test that it is securely seated in the cable connection.

4.

Connect an endoscope to the opposite end of the light cable. Note: A scope adapter may be required to connect the cable to the endoscope. See the light cable user manual for more detail. Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions.

Note: To remove the light cable, place the light source in Standby mode and disable ENV mode. Then, turn the jaw handle clockwise until the latch opens. 13

Connecting an IRIS Ureteral Kit To activate IRIS mode, an IRIS Ureteral Kit (0220-180-518) must be connected to the light source. White Light mode and ENV mode do not require connection to an IRIS Ureteral Kit. The IRIS connectors on the light source emit a Class 1 laser when IRIS mode is activated. To assure proper and safe laser application in IRIS mode, connect only the Stryker IRIS Ureteral Kit to the IRIS connectors. Do not attempt to use any other fiber optic light guides or emitting fibers. Do not attempt to operate the light source with an IRIS Ureteral Kit that is cut or damaged. If the IRIS Ureteral Kit breaks during operation, disable IRIS mode, then replace the Kit. Before connecting or using an IRIS Ureteral Kit, read and be familiar with all warnings in this user manual and the IRIS Ureteral Kit user manual (P26059). Use of controls or performance of procedures other than those specified can result in hazardous laser radiation exposure. To connect an IRIS Ureteral Kit: 1. 2.

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Make sure the light source is powered off, or place it in Standby mode and disable IRIS mode. Insert the light source ends of both fibers into the IRIS connectors on the front panel of the light source.

Operation Before operating the light source, read and be familiar with all warnings in this user manual. Failure to follow these warnings can result user or patient injury. Before operating the L10 AIM Light Source, ensure all system components have been set up according to the instructions in the Setup section. ENV mode requires all of the equipment listed in the ENV Mode Requirements section in order to achieve the intended results. IRIS mode requires all of the equipment listed in the IRIS Mode Requirements section in order to achieve the intended results.

Powering the Console On and Off 1.

To power on the console, press the power button on the front panel. The touchscreen will display the default White Light screen and indicate that the light source is in Standby mode. Note: The light source will not illuminate unless a light cable is connected to the cable port.

2.

To power off the console, press the power button on the front panel.

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Activating White Light Mode White Light mode activates the LED diodes in the light source so it can generate visible light. Note: Activating White Light mode is also required as a preliminary step to activate ENV mode or IRIS mode. While ENV mode is activated, it automatically disables the white light output. While IRIS mode is activated, the user can return to the White Light screen to toggle the white light output to Active or Standby. Follow the steps below to activate White Light mode. 1. 2. 3.

Ensure a Stryker light cable is connected to the light source. See the Connecting a Light Cable section for more information. On the default White Light screen, press the touchscreen power button so it appears green and the word “Active” appears above it. Adjust the White Light brightness level by pressing the plus or minus buttons.

2 3

Placing the Light Source in Standby Mode Standby mode reduces white light output to a minimum, thereby reducing the heat generated at the tip of the light cable or scope when the light source is not being used. To help prevent burns to the patient, user or inanimate objects and possible fire, always put the light source in Standby mode whenever the endoscope is removed from the light cable. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in Standby mode and therefore may still result in fire and/ or burns to the patient, user or inanimate objects if not used properly. Do not place the scope or the light cable on the patient, on the drapes, or other flammable material, even when the device is in Standby mode. 16

To place the light source in Standby mode: 1.

On the default White Light screen, press the touchscreen power button so it appears gray and the word “Standby” appears above it.

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Activating ENV Mode Endoscopic Near-Infrared Visualization (ENV) mode activates the Class 1M laser in the light source and enables fluorescence imaging. Before using ENV mode, read and follow all warnings in this user manual. Use of controls or performance of procedures other than those specified can result in hazardous radiation exposure. Laser emissions from the light source in ENV mode can cause injury to the user or patient’s eyes. See the ENV Mode Requirements section for equipment requirements. Use ENV mode only with the specified equipment. Note: See the 1588 AIM Video Camera user manual (P29923 English, P29924 multilingual) for additional controls over ENV fluorescence. Follow the steps below to activate ENV mode. 1.

Ensure an AIM SafeLight cable is connected to the light source. ENV mode will not function unless an AIM SafeLight cable is properly connected. See the Connecting a Light Cable section for more information. Note: When an AIM SafeLight cable is properly connected to the light source, an image of a light cable with a green connector will appear at the top-right of the touchscreen in ENV mode.

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